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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device conformer, ophthalmic, biological tissue
Regulation Description Ophthalmic conformer.
Definition The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
Product CodeNQB
Regulation Number 886.3130
Device Class 2